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Related Experiment Videos

Should study subjects see their previous responses: data from a randomized control trial.

G H Guyatt1, M Townsend, J L Keller

  • 1Department of Medicine, McMaster University, Hamilton, Ontario, Canada.

Journal of Clinical Epidemiology
|January 1, 1989
PubMed
Summary
This summary is machine-generated.

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Providing previous responses to patients using the Chronic Respiratory Disease Questionnaire (CRQ) improved the validity of subjective health status measures in clinical trials. This informed method enhanced data correlation and responsiveness.

Area of Science:

  • Clinical Medicine
  • Pulmonary Medicine
  • Health Outcomes Research

Background:

  • Assessing health status in clinical trials relies on subjective patient-reported outcomes.
  • The Chronic Respiratory Disease Questionnaire (CRQ) is a key tool for evaluating quality of life in chronic airflow limitation.
  • The impact of providing previous responses on questionnaire validity remains under investigation.

Purpose of the Study:

  • To compare the relative merits of administering the CRQ with previous responses available (informed) versus unavailable (blind).
  • To determine if the informed method enhances the validity and responsiveness of subjective health status measures in clinical trials.

Main Methods:

  • A randomized, double-blind trial involving bronchodilator administration in patients with chronic airflow limitation.

Related Experiment Videos

  • Administration of both blind and informed versions of the CRQ to assess responsiveness.
  • Statistical analysis of CRQ dimensions, spirometry, 6-minute walk distance, and global ratings.

    • Main Results:

    • Responsiveness of informed versus blind CRQ administration was comparable for three of four dimensions.
    • The informed method showed potentially increased responsiveness for the emotional function dimension.
    • Changes in informed CRQ dimensions (dyspnea, fatigue) correlated more strongly with objective measures and global ratings than blind administration.

    Conclusions:

    • Providing prior patient responses during CRQ administration can improve the validity of subjective health status measures.
    • The informed method offers enhanced correlation with objective clinical endpoints and global assessments.
    • This approach holds potential for refining the assessment of treatment effects in clinical trials for chronic respiratory diseases.